Policy on Biosafety

Office of Research
Policy 4.4
Effective Date: 7/17/2023
Last Updated: Spring 2026

I. Policy Summary

Research involving recombinant DNA (rDNA), recombinant or synthetic nucleic acid molecules (r/sNA), a variety of experimentation involving other hazardous biological materials (e.g. infectious agents), potentially hazardous agents (e.g., select agents and toxins of biological origin), and any laboratory- or greenhouse-contained transgenic experiments at NJIT require oversight by an Institutional Biosafety Committee (IBC).

II. Policy Purpose

NJIT has both legal and ethical obligations to ensure that all NJIT research projects involving recombinant or synthetic nucleic acid molecules, and hazardous biological materials and other potentially hazardous agents are conducted in a manner that protects the researchers, community, and environment from any accidental exposure or unintentional release of infectious agents and toxins. This policy describes the principles that govern the review, approval, reporting, record keeping, and monitoring of research involving hazardous biological materials and other hazardous materials in compliance with all applicable regulations and policies.

III. Policy Scope and Applicability

As a recipient of funding from the NIH and other Federal sources, NJIT is expected to follow the NIH Guidelines when conducting research with recombinant or synthetic nucleic acid molecules, including the creation and use of organisms and viruses containing recombinant or synthetic nucleic acid molecules. The NIH Guidelines require that most work involving recombinant or synthetic nucleic acid molecules require registration with, review by, and approval from the IBC of the organization planning to conduct the research. NJIT also requires IBC review and approval for a variety of experimentations that involve hazardous biological materials and other potentially hazardous agents. The IBC is responsible for reviewing research with hazardous and potentially hazardous biological materials and assess the adequacy of the proposed biosafety containment level to protect the researchers, the public, and the environment from the associated risks. This policy is in effect for all units of NJIT regardless of funding and applies to all research involving recombinant or synthetic nucleic acid molecules, hazardous biological materials and other potentially hazardous agents.

IV. Definitions

Appropriate Biosafety Levels (BSL) are established in conformance with regulations or guidelines from federal, state, and local agencies including, but not limited to:
Centers for Disease Control and Prevention (CDC)
National Institutes of Health (NIH)
United States Department of Agriculture (USDA) Animal and Plant Health Inspection Service (APHIS)
Occupational Health and Health Administration (OSHA)

Dual Use Research of Concern (DURC) is life sciences research that, based on current understanding, can be reasonably anticipated to provide knowledge, information, products, or technologies that could be directly misapplied to pose a significant threat with broad potential consequences to public health and safety, agricultural crops and other plants, animals, the environment, materiel, or national security.

Hazardous Biological Materials are any biological or biologically derived material or, any material which, either by accident or design, contains biological agents that present a risk or potential risk to the health of humans, animals, or the environment. They include, but are not limited to, all of the following:

Infectious organisms (e.g., bacteria, chlamydiae, fungi, parasites, prions, rickettsias, and viruses) which can cause disease in humans, animals, or plants or significant environmental or agricultural impact.
Materials that may harbor infectious organisms, such as human or primate tissues, fluids, cells, or cell cultures.
Recombinant or synthetic Nucleic Acid (r/sNA) are molecules that a) are constructed by joining nucleic acid molecules and b) that can replicate in a living cell, i.e., recombinant nucleic acids. They are constructed outside of living cells and may also result from replication of previously constructed recombinant molecules.

Institutional Biosafety Committee (IBC) is a Committee established under the NIH Guidelines to provide local review and oversight of nearly all forms of research utilizing recombinant or synthetic nucleic acid molecules. NJIT has also assigned its IBC the responsibility of reviewing experimentations that involve biological materials and other potentially hazardous agents. The Committee approves procedures for procurement, use, storage, transportation and disposal of biohazardous material.

Potentially Hazardous Agents (select agents and toxins) have the potential to cause harm to human health or physical harm. Select agents are biological agents and toxins that have been determined to have the potential to pose a severe threat to public health and safety, to animal and plant health, or to animal or plant products. The Federal Select Agent program regulates 68 select agents and toxins.

Recombinant DNA (rDNA) is an artificially made DNA strand that is formed by the combination of two or more gene sequences.

Transgenic organisms and products are animals, plants, microbes, or products which have been modified by genetic engineering.

V. Policy Statement

NJIT complies with NIH Guidelines to promote the safe conduct of research involving recombinant or synthetic nucleic acid molecules as well as experiments that involve biological materials and other potentially hazardous agents. NJIT is committed to developing defensive mechanisms against naturally occurring disease and bioterrorism, and at the same time, protecting the health, safety, and security of our communities while conducting research on genetically modified organisms and hazardous biological materials and potentially hazardous agents. All such research at NJIT must be registered, reviewed, and approved by the IBC before work is started.

VI. Procedures

A Registration Document For Biohazards must be submitted by the Principal Investigator to the IBC to initiate the review and approval process prior to the start of any work. For projects that are currently registered, any changes in the facilities, personnel, and experimental protocols associated with them must be updated by submitting an Amendment to Registration Document For Biohazards.

Disposal of Recombinant or Synthetic Nucleic Acid Materials, hazardous biological materials, and potentially hazardous agents must be disposed of via the University’s Biological Waste management system. None should be disposed of via the ordinary trash.

Any extramural or intramural transfer of recombinant/synthetic nucleic acid materials, hazardous biological materials, and potentially hazardous agents, and transgenic organisms, including transgenic animals and transgenic plants are prohibited without the written approval of the IBC.

Any significant research-related incident involving recombinant DNA, recombinant/synthetic nucleic acid materials, hazardous biological materials, and potentially hazardous agents, and transgenic organisms must be reported immediately to the Biosafety Officer. Such incidents include researchrelated spills and accidents in BSL-2 laboratories resulting in an overt exposure as well as inadvertent release or improper disposal of biohazardous or recombinant/synthetic nucleic acid materials.

VII. Roles & Responsibilities

The NJIT IBC, as mandated by the NIH Guidelines, is responsible for assessing the biosafety containment level for research involving recombinant DNA and synthetic nucleic acid molecules. It is also responsible for overseeing experimentations that involve biological materials and other potentially hazardous agents. The NJIT IBC currently oversees research work involving:

Recombinant DNA and synthetic nucleic acid molecules (this includes human gene transfer studies)
Infectious agents
Biological toxins
Human-derived tissues, fluids, cells
Certain animal-derived tissues, fluids, cells (i.e., from non-human primates, ruminants, swine, chickens or other fowl, or wild vertebrate animals)
Federally-regulated toxins of biological origins, Select Agents, experiments with Dual Use Research of Concern potential, and research requiring BSL-2 containment

In the event that the IBC or the Biosafety Officer becomes aware of any research-related incident, they report them to the NJIT Office of Research. Attempts will be made to rectify the problem by conforming to the requirements of the NIH Guidelines. If an occurrence of non-compliance with the NIH Guidelines is identified, a complete report of the incident will be forwarded to NIH OSP along with any recommended actions within 30 days.

The Office of Research and the Biosafety Officer will maintain a record of all registration, renewal, and amendment applications as well as the proceedings of the IBC meetings.

VIII. Authority and Responsibility

The Office of Research holds institutional authority for the issues covered in this policy. Questions related to this policy are to be directed to the director, research compliance and services.

Related Policies and Regulations

https://osp.od.nih.gov/wp-content/uploads/NIH_Guidelines.pdf (NIH Guidelines)

https://www.ecfr.gov/current/title-9/chapter-I/subchapter-E/part-121/se… (9 CFR 121.12: Biosafety)

https://www.ecfr.gov/current/title-42/chapter-I/subchapter-F/part-73 (42 CFR 73: Select Agents and Toxins)

https://www.ecfr.gov/current/title-9/chapter-I/subchapter-E/part-121 (9 CFR 121: POSSESSION, USE,

AND TRANSFER OF SELECT AGENTS AND TOXINS)

https://www.cdc.gov/labs/pdf/SF__19_308133-A_BMBL6_00-BOOK-WEB-final-3… (CDC: Biosafety Manual)

https://www.ars.usda.gov/northeast-area/docs/she/biological-safety-manu… (USDA: Biological Safety Manual)

https://www.selectagents.gov/sat/list.htm?CDC_AA_refVal=https%3A%2F%2Fw…% 2FSelectAgentsandToxinsList.html (CDC: Select Agents and Toxins List)

https://www.phe.gov/s3/dualuse/Documents/durc-policy.pdf (US DURC Policy)

https://www.osha.gov/bloodbornepathogens/standards#:~:text=What%20is%20…. and

https://www.osha.gov/sites/default/files/publications/bbfact01.pdf (OSHA’s Bloodborne Pathogens Standard)